NPA: dispense despite anticipated FMD alerts
The NPA is advising its members that most medicines can still be dispensed even if they return an alert from the Falsified Medicines Directive (FMD) database, in the early phase of implementation.
Speaking before Saturday’s deadline for full implementation of the directive it said it will be advising that medicines should only be withheld if there is a clear indication they are counterfeit.
The NPA will be one of the few sources of accessible advice on the morning of implementation, via its call centre which is staffed by pharmacists and open on Saturdays.
Gareth Jones, head of corporate affairs for the NPA, said: “There will be very few medicines packs in the supply chain that have the new FMD safety feature and some that do may still return an error message.
“Unless there is a clear indication that the medicine is counterfeit, or there is some other significant overriding factor, then the medicine should be dispensed.”
The NPA advice comes as both the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK FMD Working Group for Community Pharmacy today (FEB 7) issue new written guidance on FMD.
The Working Group has designed a guidance grid that details the eleven most common error messages and MHRA has issued guidance and assurances that it will take a pragmatic and flexible approach to enforcement.
Mr Jones said: “The NPA has been working closely with the MHRA both in its own right and with other pharmacy bodies as part of the Working Group.
“The MHRA has listened and has issued some extremely helpful guidance that acknowledges the difficulties and realities around FMD.
“Many NPA members will be FMD compliant but it will take some time for the rest of the medicines supply chain to fully comply.
“In the meantime our advice to members is they must be mindful of the relevant guidance and be making efforts to comply, but ultimately they must put their patients’ needs first.”
Further guidance, including the guidance grid, is available at the Working Group’s website, https://fmdsource.co.uk/resources/eu-fmd-scanning-and-error-messages/
The full MHRA statement and its latest guidance is available at https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features
The NPA will continue to update its member resources, which includes FMD SOPs, available at www.npa.co.uk/FMD